Salute e Benessere
Serendex Pharmaceuticals And CMC Biologics Enter Exclusive Agreement On Factor VIIa
CMC Biologics, which provides bioprocessing solutions to pharmaceutical and biotechnology companies, will develop, manufacture and supply Factor VIIa bulk drug substance for acute pulmonary administration for pre‑clinical and clinical studies as well as for commercialization on behalf of Serendex Pharmaceuticals.
said Kim Arvid Nielsen , CEO, Serendex Pharmaceuticals.
The contract is a great leap forward for Serendex Pharmaceuticals, which could lead to a market approval for FVIIa within five years.
Serendex Pharmaceuticals is listed at Oslo Axess and develop drugs to treat respiratory conditions such as PAP (Pulmonary Alveolar Proteinosis), BE (Bronchiectasis), CF (Cystic Fibrosis related lung infections) and DAH (Diffuse Alveolar Hemorrhage). The conditions have either an acute or a chronical medical need and we have therefore obtained Orphan Drug Designation (ODD) for many of our indications in both Europe and USA .
Common for all our drugs is that they are inhaled or induced to the lungs of the patient. This improves the risk/efficacy ratio of the drug and treatment.
The development strategy is a reposition strategy, e.g. finding new indications and administration routes for existing drugs. Repositioning reduces the risk and the time to market and thus, the costs of development.
You can read more about Serendex Pharmaceuticals A/S here: www.serendex.com
CMC Biologics is leading the industry among CMO's in reliability, technical excellence, and quality – Right and On Time. With three facilities in the USA and Europe , the Company provides fully integrated biopharmaceutical development and manufacturing solutions to clients globally. The Company has proven expertise in delivering custom solutions for the scaleup and cGMP manufacture of protein- based therapeutics for preclinical, clinical trials and commercial production. The Company's wide range of integrated services includes cell line development, bioprocess development, formulation and comprehensive analytical testing. Clients can also benefit from CMC Biologics' proprietary CHEF1® expression system for mammalian production. CMC Biologics has fully segregated microbial fermentation and mammalian cell culture suites and offers both fed-batch and perfusion production processes.
More detailed information can be found at www.cmcbiologics.com.